Balloon Elution and Late Loss Optimization (BELLO) Study

Coronary Artery Disease Clinical Trial

— BELLO  

Official title:

Balloon Elution and Late Loss Optimization (BELLO) Study: A Multicentre Randomized Study of the IN.PACT Falcon™ Paclitaxel Drug-eluting Balloon to Reduce Restenosis in Small Coronary Vessels

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01086579
• Other study ID #: BELLO
• Status: Active, not recruiting
• Phase: N/A
• First received: March 11, 2010
• Last updated: August 13, 2013
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: August 2013
• Source: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms:

1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS).

2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.

Eligible subjects with coronary artery disease in a small vessel (reference diameter<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria

The objective of the study is to assess the non-inferiority of the DEB to the PES as regards to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by quantitative coronary angiography and is based on the following assumptions:

1. The means of LLL in the 2 groups are precisely equal

2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials

3. A non-inferiority margin of 0.25mm between groups is clinically unimportant

Based on these assumptions:

1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB)

2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is <0.25mm (i.e. DEB is non-inferior to PES)

3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES <0 (i.e. DEB is superior to PES) Based on the above calculations, a sample size of 77 patients will be required in each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or not presenting for follow-up angiography, a total of 182 patients (91 in each group) will be randomized.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: May 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Patient providing written informed consent.

• Patients with stable angina pectoris (Canadian Cardiovascular Society [CCS] 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.

• Patients who are eligible for coronary revascularization (angioplasty and/or CABG).

• Female patients with child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception.

Angiographic Inclusion Criteria:

• Native coronary artery.

• De novo lesion.

• Reference vessel diameter < 2.8mm by visual estimate.

• Target lesion with a visually estimated stenosis >50%.

• Target lesion length < 25mm by visual estimate.

• A maximum of 2 epicardial vessels requiring revascularization.

• A maximum of 2 target lesions can be included (In the case of treatment of more than one lesion, the treatment selected will remain the same).

Exclusion Criteria:

• Patients unable to give informed consent.

• Patients enrolled in another study with any investigational drug or device within the past 30 days.

• Patients scheduled for a major surgical intervention within 6 months of enrolment in the study.

• Patients with acute (< 24h) or recent (= 48 hours) myocardial infarction.

• Patients with a contraindication to an emergency coronary bypass surgery.

• Any individual who may refuse a blood transfusion.

• Patients with serum creatinine >2.0mg/dL or >180umol/L.

• Patients with severe congestive heart failure.

• Patients who had a cerebral stroke <6 months prior to the Index Procedure.

• EF (Ejection Fraction) < 30%.

• Patients with any known allergy, hypersensitivity or intolerance to acetylsalicylic acid (ASA), Clopidogrel or Ticlopidine, Paclitaxel.

• Any known allergy to contrast medium that cannot be pre-treated.

Angiographic exclusion criteria:

• >2 epicardial vessels requiring revascularization.

• Target lesion distance from the ostium of left anterior descending coronary artery (LAD)/left circumflex coronary artery (LCX)/right coronary artery (RCA) is < 5 mm.

• Target lesion is located in either a venous or arterial graft.

• Target vessel contains a previously implanted stent.

• Angiographic evidence of thrombus at the target site.

• Chronic total occlusions.

• Restenotic lesions.

• Bifurcation lesions which the operator decides a 2-stent technique as intention-to-treat is required OR bifurcations with side branches = 2.5mm.

• Failure to successfully treat non-target lesions within the target vessel (non-target lesions must be treated prior the target lesion).

• Greater than 2 non-target lesions treated during the index procedure.

• Previous Percutaneous Coronary Intervention (PCI) within the last 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Coronary Artery Bypass Graft (CABG)
• Taxus (Paclitaxel eluting stent)
Percutaneous transluminal coronary angioplasty (PTCA) with stent

Locations

Country	Name	City	State
Italy	Irccs Fondazione Centro S.Raffaele Del Monte Tabor	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Lumen Loss (LLL) at 6 months follow-up defined as the difference between postprocedural minimum luminal diameter and follow-up minimum luminal diameter, as assessed by quantitative coronary angiography		6 Month	No
Secondary	Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.		day 1	Yes
Secondary	Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization		day 1	Yes
Secondary	MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure		30 days, 6 months,1, 2, 3 years	Yes
Secondary	Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure		6 months,1, 2, 3 years	Yes
Secondary	Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure		6 months,1, 2, 3 years	Yes
Secondary	Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year		1 Year	Yes
Secondary	Binary Restenosis rate at 6 months follow-up		6 months	Yes

External Links

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